[Code of Federal Regulations] [Title 40, Volume 21] [Revised as of July 1, 2007] From the U.S. Government Printing Office via GPO Access [CITE: 40CFR132.2] [Page 483-487] TITLE 40--PROTECTION OF ENVIRONMENT CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PART 132_WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM--Table of Contents Sec. 132.2 Definitions. The following definitions apply in this part. Terms not defined in this section have the meaning given by the Clean Water Act and EPA implementing regulations. Acute-chronic ratio (ACR) is a standard measure of the acute toxicity of a material divided by an appropriate measure of the chronic toxicity of the same material under comparable conditions. Acute toxicity is concurrent and delayed adverse effect(s) that results from an acute exposure and occurs within any short observation period which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism. Adverse effect is any deleterious effect to organisms due to exposure to a substance. This includes effects which are or may become debilitating, harmful or [[Page 484]] toxic to the normal functions of the organism, but does not include non- harmful effects such as tissue discoloration alone or the induction of enzymes involved in the metabolism of the substance. Bioaccumulation is the net accumulation of a substance by an organism as a result of uptake from all environmental sources. Bioaccumulation factor (BAF) is the ratio (in L/kg) of a substance's concentration in tissue of an aquatic organism to its concentration in the ambient water, in situations where both the organism and its food are exposed and the ratio does not change substantially over time. Bioaccumulative chemical of concern (BCC) is any chemical that has the potential to cause adverse effects which, upon entering the surface waters, by itself or as its toxic transformation product, accumulates in aquatic organisms by a human health bioaccumulation factor greater than 1000, after considering metabolism and other physicochemical properties that might enhance or inhibit bioaccumulation, in accordance with the methodology in appendix B of this part. Chemicals with half-lives of less than eight weeks in the water column, sediment, and biota are not BCCs. The minimum BAF information needed to define an organic chemical as a BCC is either a field-measured BAF or a BAF derived using the BSAF methodology. The minimum BAF information needed to define an inorganic chemical, including an organometal, as a BCC is either a field-measured BAF or a laboratory-measured BCF. BCCs include, but are not limited to, the pollutants identified as BCCs in section A of Table 6 of this part. Bioconcentration is the net accumulation of a substance by an aquatic organism as a result of uptake directly from the ambient water through gill membranes or other external body surfaces. Bioconcentration factor (BCF) is the ratio (in L/kg) of a substance's concentration in tissue of an aquatic organism to its concentration in the ambient water, in situations where the organism is exposed through the water only and the ratio does not change substantially over time. Biota-sediment accumulation factor (BSAF) is the ratio (in kg of organic carbon/kg of lipid) of a substance's lipid-normalized concentration in tissue of an aquatic organism to its organic carbon- normalized concentration in surface sediment, in situations where the ratio does not change substantially over time, both the organism and its food are exposed, and the surface sediment is representative of average surface sediment in the vicinity of the organism. Carcinogen is a substance which causes an increased incidence of benign or malignant neoplasms, or substantially decreases the time to develop neoplasms, in animals or humans. The classification of carcinogens is discussed in section II.A of appendix C to part 132. Chronic toxicity is concurrent and delayed adverse effect(s) that occurs only as a result of a chronic exposure. Connecting channels of the Great Lakes are the Saint Mary's River, Saint Clair River, Detroit River, Niagara River, and Saint Lawrence River to the Canadian Border. Criterion continuous concentration (CCC) is an estimate of the highest concentration of a material in the water column to which an aquatic community can be exposed indefinitely without resulting in an unacceptable effect. Criterion maximum concentration (CMC) is an estimate of the highest concentration of a material in the water column to which an aquatic community can be exposed briefly without resulting in an unacceptable effect. EC50 is a statistically or graphically estimated concentration that is expected to cause one or more specified effects in 50 percent of a group of organisms under specified conditions. Endangered or threatened species are those species that are listed as endangered or threatened under section 4 of the Endangered Species Act. Existing Great Lakes discharger is any building, structure, facility, or installation from which there is or may be a ``discharge of pollutants'' (as defined in 40 CFR 122.2) to the Great Lakes System, that is not a new Great Lakes discharger. [[Page 485]] Federal Indian reservation, Indian reservation, or reservation means all land within the limits of any Indian reservation under the jurisdiction of the United States Government, notwithstanding the issuance of any patent, and including rights-of-way running through the reservation. Final acute value (FAV) is (a) a calculated estimate of the concentration of a test material such that 95 percent of the genera (with which acceptable acute toxicity tests have been conducted on the material) have higher GMAVs, or (b) the SMAV of an important and/or critical species, if the SMAV is lower than the calculated estimate. Final chronic value (FCV) is (a) a calculated estimate of the concentration of a test material such that 95 percent of the genera (with which acceptable chronic toxicity tests have been conducted on the material) have higher GMCVs, (b) the quotient of an FAV divided by an appropriate acute-chronic ratio, or (c) the SMCV of an important and/or critical species, if the SMCV is lower than the calculated estimate or the quotient, whichever is applicable. Final plant value (FPV) is the lowest plant value that was obtained with an important aquatic plant species in an acceptable toxicity test for which the concentrations of the test material were measured and the adverse effect was biologically important. Genus mean acute value (GMAV) is the geometric mean of the SMAVs for the genus. Genus mean chronic value (GMCV) is the geometric mean of the SMCVs for the genus. Great Lakes means Lake Ontario, Lake Erie, Lake Huron (including Lake St. Clair), Lake Michigan, and Lake Superior; and the connecting channels (Saint Mary's River, Saint Clair River, Detroit River, Niagara River, and Saint Lawrence River to the Canadian Border). Great Lakes States and Great Lakes Tribes, or Great Lakes States and Tribes means the States of Illinois, Indiana, Michigan, Minnesota, New York, Ohio, Pennsylvania, and Wisconsin, and any Indian Tribe as defined in this part which is located in whole or in part within the drainage basin of the Great Lakes, and for which EPA has approved water quality standards under section 303 of the Clean Water Act or which EPA has authorized to administer an NPDES program under section 402 of the Clean Water Act. Great Lakes System means all the streams, rivers, lakes and other bodies of water within the drainage basin of the Great Lakes within the United States. Human cancer criterion (HCC) is a Human Cancer Value (HCV) for a pollutant that meets the minimum data requirements for Tier I specified in appendix C of this part. Human cancer value (HCV) is the maximum ambient water concentration of a substance at which a lifetime of exposure from either: drinking the water, consuming fish from the water, and water-related recreation activities; or consuming fish from the water, and water-related recreation activities, will represent a plausible upper-bound risk of contracting cancer of one in 100,000 using the exposure assumptions specified in the Methodologies for the Development of Human Health Criteria and Values in appendix C of this part. Human noncancer criterion (HNC) is a Human Noncancer Value (HNV) for a pollutant that meets the minimum data requirements for Tier I specified in appendix C of this part. Human noncancer value (HNV) is the maximum ambient water concentration of a substance at which adverse noncancer effects are not likely to occur in the human population from lifetime exposure via either: drinking the water, consuming fish from the water, and water- related recreation activities; or consuming fish from the water, and water-related recreation activities using the Methodologies for the Development of Human Health Criteria and Values in appendix C of this part. Indian Tribe or Tribe means any Indian Tribe, band, group, or community recognized by the Secretary of the Interior and exercising governmental authority over a Federal Indian reservation. LC50 is a statistically or graphically estimated concentration that is expected to be lethal to 50 percent of a group of organisms under specified conditions. [[Page 486]] Load allocation (LA) is the portion of a receiving water's loading capacity that is attributed either to one of its existing or future nonpoint sources or to natural background sources, as more fully defined at 40 CFR 130.2(g). Nonpoint sources include: in-place contaminants, direct wet and dry deposition, groundwater inflow, and overland runoff. Loading capacity is the greatest amount of loading that a water can receive without violating water quality standards. Lowest observed adverse effect level (LOAEL) is the lowest tested dose or concentration of a substance which resulted in an observed adverse effect in exposed test organisms when all higher doses or concentrations resulted in the same or more severe effects. Method detection level is the minimum concentration of an analyte (substance) that can be measured and reported with a 99 percent confidence that the analyte concentration is greater than zero as determined by the procedure set forth in appendix B of 40 CFR part 136. Minimum Level (ML) is the concentration at which the entire analytical system must give a recognizable signal and acceptable calibration point. The ML is the concentration in a sample that is equivalent to the concentration of the lowest calibration standard analyzed by a specific analytical procedure, assuming that all the method-specified sample weights, volumes and processing steps have been followed. New Great Lakes discharger is any building, structure, facility, or installation from which there is or may be a ``discharge of pollutants'' (as defined in 40 CFR 122.2) to the Great Lakes System, the construction of which commenced after March 23, 1997. No observed adverse effect level (NOAEL) is the highest tested dose or concentration of a substance which resulted in no observed adverse effect in exposed test organisms where higher doses or concentrations resulted in an adverse effect. No observed effect concentration (NOEC) is the highest concentration of toxicant to which organisms are exposed in a full life-cycle or partial life-cycle (short-term) test, that causes no observable adverse effects on the test organisms (i.e., the highest concentration of toxicant in which the values for the observed responses are not statistically significantly different from the controls). Open waters of the Great Lakes (OWGLs) means all of the waters within Lake Erie, Lake Huron (including Lake St. Clair), Lake Michigan, Lake Ontario, and Lake Superior lakeward from a line drawn across the mouth of tributaries to the Lakes, including all waters enclosed by constructed breakwaters, but not including the connecting channels. Quantification level is a measurement of the concentration of a contaminant obtained by using a specified laboratory procedure calibrated at a specified concentration above the method detection level. It is considered the lowest concentration at which a particular contaminant can be quantitatively measured using a specified laboratory procedure for monitoring of the contaminant. Quantitative structure activity relationship (QSAR) or structure activity relationship (SAR) is a mathematical relationship between a property (activity) of a chemical and a number of descriptors of the chemical. These descriptors are chemical or physical characteristics obtained experimentally or predicted from the structure of the chemical. Risk associated dose (RAD) is a dose of a known or presumed carcinogenic substance in (mg/kg)/day which, over a lifetime of exposure, is estimated to be associated with a plausible upper bound incremental cancer risk equal to one in 100,000. Species mean acute value (SMAV) is the geometric mean of the results of all acceptable flow-through acute toxicity tests (for which the concentrations of the test material were measured) with the most sensitive tested life stage of the species. For a species for which no such result is available for the most sensitive tested life stage, the SMAV is the geometric mean of the results of all acceptable acute toxicity tests with the most sensitive tested life stage. Species mean chronic value (SMCV) is the geometric mean of the results of all acceptable life-cycle and partial life-cycle toxicity tests with the species; [[Page 487]] for a species of fish for which no such result is available, the SMCV is the geometric mean of all acceptable early life-stage tests. Stream design flow is the stream flow that represents critical conditions, upstream from the source, for protection of aquatic life, human health, or wildlife. Threshold effect is an effect of a substance for which there is a theoretical or empirically established dose or concentration below which the effect does not occur. Tier I criteria are numeric values derived by use of the Tier I methodologies in appendixes A, C and D of this part, the methodology in appendix B of this part, and the procedures in appendix F of this part, that either have been adopted as numeric criteria into a water quality standard or are used to implement narrative water quality criteria. Tier II values are numeric values derived by use of the Tier II methodologies in appendixes A and C of this part, the methodology in appendix B of this part, and the procedures in appendix F of this part, that are used to implement narrative water quality criteria. Total maximum daily load (TMDL) is the sum of the individual wasteload allocations for point sources and load allocations for nonpoint sources and natural background, as more fully defined at 40 CFR 130.2(i). A TMDL sets and allocates the maximum amount of a pollutant that may be introduced into a water body and still assure attainment and maintenance of water quality standards. Tributaries of the Great Lakes System means all waters of the Great Lakes System that are not open waters of the Great Lakes, or connecting channels. Uncertainty factor (UF) is one of several numeric factors used in operationally deriving criteria from experimental data to account for the quality or quantity of the available data. Uptake is acquisition of a substance from the environment by an organism as a result of any active or passive process. Wasteload allocation (WLA) is the portion of a receiving water's loading capacity that is allocated to one of its existing or future point sources of pollution, as more fully defined at 40 CFR 130.2(h). In the absence of a TMDL approved by EPA pursuant to 40 CFR 130.7 or an assessment and remediation plan developed and approved in accordance with procedure 3.A of appendix F of this part, a WLA is the allocation for an individual point source, that ensures that the level of water quality to be achieved by the point source is derived from and complies with all applicable water quality standards. Wet weather point source means any discernible, confined and discrete conveyance from which pollutants are, or may be, discharged as the result of a wet weather event. Discharges from wet weather point sources shall include only: discharges of storm water from a municipal separate storm sewer as defined at 40 CFR 122.26(b)(8); storm water discharge associated with industrial activity as defined at 40 CFR 122.26(b)(14); discharges of storm water and sanitary wastewaters (domestic, commercial, and industrial) from a combined sewer overflow; or any other stormwater discharge for which a permit is required under section 402(p) of the Clean Water Act. A storm water discharge associated with industrial activity which is mixed with process wastewater shall not be considered a wet weather point source.